1. Field of the Invention (Technical Field)
The invention relates to a readily portable Breast Self Exam apparatus which can be attached to a mirror to facilitate both understanding and documentation of the normal breast geography (visual, sensory, and physical) and thus simplify the recognition of abnormal findings discovered by women and/or their health care professionals.
2. Background Art
Breast cancer kills approximately 250,000 women worldwide each year. It is the number one killer of women between the ages of 35 and 50. Mammography, heavily relied upon as a mass screening tool for women 50 and older, has a false negative rate of 25% in women age 40-49 and 40% in women between the ages of 30-39. This is thought to be largely due to the high density of breast tissue in women of this age group along with their higher incidence of "fast growing" breast cancer tumors. This leaves a large deficit in tools for detecting breast cancer in this under 50 age group. "Fast growing" breast cancers can double in size every 3 days. In other words, it can take as little as three months for a single breast cancer cell to double 30 times and produce a 1 cm size tumor. Thus, a breast cancer can grow to 4 cm's (Stage III to Stage IV) in the 9 month period between clinical exams and this is occurring with alarming frequency in the under 50 age group.
Nevertheless according to the World Organization of Family Practitioners, 9 out of 10 breast cancers are discovered by women themselves. Women in the 35-50 age group are not being adequately evaluated for breast cancer when they present with classic signs and symptoms due largely to the fact that only 25% of breast cancers occur in women under the age of 50 and the lack of effective imaging tools for detecting and documenting these fast growing tumors.
Several different breast self exam (BSE) techniques are freely available through nationally recognized agencies. None of these, however, deals directly with the emotional and sensational aspects of performing breast self-exams. For example, although pain and swelling on any part of the body is universally recognized as a significant sign of injury or disease, when these sensations are experienced by a woman in relation to her breasts, she is routinely instructed by her health care professional to ignore these findings as if they are of no importance. This is a verbal cue to a woman to ignore what is occurring in her breasts. Yet, the same health care professional may ask her to perform monthly breast self-exams, and document that she is compliant with the plan of care. Without adequate education related to the breasts, reaction to normal hormonal fluctuations and the resulting cyclic sensations such as pain, swelling, tenderness, etc.; many women are frightened away from performing breast self-exams when they experience these unpleasant sensations, and they are ignored by their health care providers. In addition, the female breast and its underlying structure are complex to evaluate and to describe. For example, a clinical sign of breast cancer may be palpable with a woman in one position and totally concealed when she changes to another position. A woman attempting to perform BSE's, remembers her findings from month to month and communicates information about her normal breast tissue and the abnormalities found is unfairly handicapped. She has been given all the responsibility and none of the tools to do her job effectively. Further more, the amount of information to recall and explain to a health care provider is directly proportional to the amount of breast tissue to be examined, the larger the breast, the more impossible the situation becomes.
In addition, the incidence of breast cancer in younger women is on the rise and the cause remains unknown. What's more, due to the problems identified above, any breast cancers in younger women, while being detected and brought to their health care practitioner's attention are going "undiagnosed" until late stage disease because the early stages are not being adequately documented in the health care professional's office.
It seems only natural that if both women and their health care providers are provided with a simple, concise breast exam tool, educated in basic breast anatomy and physiology, informed of all signs and symptoms of breast cancer, schooled in the benefits of precise documentation of both normal (baseline) breast findings and abnormal breast findings, and instructed on how and when to communicate concerns; communication would improve, early diagnosis would be facilitated and fewer women would be dying of breast cancer.
U.S. Pat. No. 5,207,582, to Michelson is a non-portable, complex, multi-part device designed primarily for in shower or bathroom use. The device and method are designed to locate masses in a single view. The present invention is a portable device intended for use in three different positions including a supine position for not only locating masses, but also for documenting changes in the breast for location, size and other perceived changes in three different views.
U.S. Pat. No. 5,494,442, to Hecht also a non-portable, multi-part, overlay device designed for shower use. Again, this device is designed for locating and documenting changes in masses on overlays and not for other visual and sensation changes perceived by the user. Additionally, this device only documents changes in a single view.
Other prior art systems identified focus only on documenting lumps identified by palpation within the breast, often using shower breast self exams as the source of information. Many medical experts are now in agreement that shower exams are not enough. The Breast-Mapping system is designed to document visual findings, sensations within the breast, and also palpable lumps with different colored markers, in order to document the natural geography of the breast so that change can be more readily identified by both the woman and her health care provider.
None of the prior art, however discloses a simple, economical, portable means to document the natural geography and changes of the breasts including visual and sensational patterns which can be used by both women and their health care professionals.